(More on this topic here: https://www.keionline.org/xtandi2021) On February 24, 2022, Senators Thom Tillis and Marsha Blackburn sent a letter to HHS Secretary Xavier Becerra (PDF copy). The letter refers to “petitions to march-in on a pharmaceutical product purely based on… Continue Reading
This is a letter from the three prostate cancer patient petitioners to HHS Secretary Becerra and Acting NIH Director Tabak, regarding the February 9, 2020 statement by Astellas on the Bayh-Dole march in and government rights case. The patient’s letter… Continue Reading
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Senators Elizabeth Warren (D-MA) and Angus King (I-ME) and Representative Lloyd Doggett (D-TX) wrote Secretary of HHS Xavier Becerra on February 17, 2022, urging him to move forward with the march-in petition by Robert Sachs, Clare Love and Eric Sawyer,… Continue Reading
(More on the Xtandi case here: https://www.keionline.org/xtandi2021) Astellas has issued a statement, dated February 9, 2022, on the Bayh-Dole Act and the petition to exercise march-in and government use rights in the prostate cancer drug Xtandi. It was brought to… Continue Reading
Revised February 14, 2022 Early 2000 UCLA claims work that led to the development of enzalutamide began at UCLA in early 2000. 2005 May 13, 2005. Priority date for the three patents in the Xtandi Orange Book. Patents 7709517, 8183274… Continue Reading
(Update: The NIH provided a response to our questions and comments on February 28, 2022) On February 9, 2022, Knowledge Ecology International (KEI) filed comments with the National Institutes of Health regarding the “Prospective Grant of Exclusive Patent License: Development… Continue Reading
Following the publication of the US government contract with Pfizer for the COVID-19 therapeutic Paxlovid, the petitioners of the Xtandi government use request wrote to the Department of Health and Human Services (HHS) and the National Institutes of Health (NIH)… Continue Reading
The Department of Health and Human Services (HHS) and National Institutes of Health (NIH) is currently reviewing whether to proceed with the request that the government use its rights in the prostate cancer drug Xtandi, in order to enable generic… Continue Reading
On February 2, 2022, Drs. Ameet Sarpatwari, Aaron S. Kesselheim, Jerry Avorn, and Benjamin N. Rome of Harvard Medical School and Dr. Michael S. Sinha of Northeastern University and Loyola University sent a letter to HHS Secretary Xavier Becerra in… Continue Reading